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Clinical Trials in the USA / NCT07783802
Starting soon Phase 2

A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event

NCT07783802 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-09
Last updated
2026-08-25

Condition(s) studied

AtherosclerosisCardiovascular DiseaseObesityHypertensionDiabetes Mellitus, Type 2Renal Insufficiency, Chronic

Investigational drug(s) / intervention(s)

ClazakizumabPlacebo

Clazakizumab: Administered SC

Placebo: Administered SC

Study summary

The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event.

Participation in the study will last about 9 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * hsCRP ≥2 mg/L and ≤15 mg/L at screening * At least one of the following chronic conditions: * Established atherosclerotic cardiovascular disease (ASCVD) * Obesity (body mass index (BMI) ≥30 kg/m2) * Type 2 diabetes * Hypertension * Chronic kidney disease Grade 3 or 4 Exclusion Criteria: * Acute cardiovascular event within 60 days prior to screening * Acute decompensated heart failure hospitalization within 60 days prior to screening * Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or major surgery at the time of randomization * New York Heart Association Class III or IV heart failure * Uncontrolled hypertension at screening (systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg) * Type 1 diabetes * Type 2 diabetes with Hemoglobin A1c ≥9.0% (86 mmol/mol) at screening * Nephrotic syndrome, estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m², or history of kidney transplant * Dialysis or acute kidney injury within 60 days prior to screening * Congenital/hereditary kidney disease, polycystic kidney disease, lupus nephritis, or antineutrophil cytoplasmic antibody-associated vasculitis * Active tuberculosis, untreated latent tuberculosis, or known hepatitis B or hepatitis C infection * Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening * Significant active autoimmune disease * Suspected or confirmed immunocompromised state (e.g., HIV infection) * History of peptic ulcer disease or gastrointestinal ulceration within 12 months prior to screening * History of diverticular disease, gastrointestinal perforation, or major gastrointestinal surgery * Mechanical heart valve prosthesis requiring chronic vitamin K antagonist anticoagulation * Use of colchicine within 14 days prior to screening or anticipated need during the study * Use of immunosuppressive or immunomodulatory agents, including other biologic anti-IL-6 therapies, within specified windows prior to screening * Use of systemic corticosteroids within 14 days prior to screening * Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs)

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
Heart Center Research, LLC Huntsville Alabama
Pima Heart Tucson Arizona
Eclipse Clinical Research Tucson Arizona
Thrive Clinical Research Group Glendora California
Omega Research Orlando Altamonte Springs Florida
American Research Institute Cutler Bay Florida
K2 Medical Research - Maitland Maitland Florida
Florida Institute For Clinical Research, LLC Orlando Florida
North Georgia Clinical Research Woodstock Georgia
Accellacare - DuPage Lombard Illinois
Franciscan Physician Network - Indiana Heart Physicians Indianapolis Indiana
K2 Medical Research - Foxborough Foxborough Massachusetts
Revival Research Institute, LLC Dearborn Michigan
Olive Branch Family Medical Center Olive Branch Mississippi
Excel Clinical Research, LLC Las Vegas Nevada
Palm Research Center Tenaya Las Vegas Nevada
Rochester Clinical Research - Buffalo Buffalo New York
CHEAR Center LLC The Bronx New York
Altru Health System Grand Forks North Dakota
Velocity Clinical Research, Cincinnati, Springdale Cincinnati Ohio
Suburban Research Associates West Chester Pennsylvania
Cardiology Consultants of Philadelphia Yardley Yardley Pennsylvania
Monroe Biomedical Research - Charleston North Charleston South Carolina
Horizon Clinical Research Group Cypress Texas
Cardiovascular Specialists of Willowbrook Houston Texas
Texas Cardiology Associates of Houston Kingwood Texas
Revival Research Institute, LLC McKinney Texas
Texas Institute of Cardiology, PA McKinney Texas
Ogden Clinic - Canyon View Ogden Utah
Carient Heart & Vascular - Manassas Manassas Virginia
Carient Heart and Vascular LLC-Reston Reston Virginia
CIPREC Buenos Aires Argentina
Cicemo Srl Buenos Aires Argentina
CARDIAMET Investigaciones Médicas Buenos Aires Argentina
Mautalen Salud e Investigación Buenos Aires Argentina
CEMEDIC Buenos Aires Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Buenos Aires Argentina
Fundación Respirar Buenos Aires Argentina
Instituto Médico Catamarca IMEC Rosario Argentina
Centro de Investigaciones Clinicas del Litoral Santa Fe Argentina

+ 7 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07783802 on ClinicalTrials.gov ↗ ← All trials in the USA